Evaluation of a Physical-Psychological Integrative (PPI) intervention for community-dwelling spinal cord injury survivors: Study protocol of a preliminary randomized controlled trial

Introduction There is a considerably large group of community-dwelling spinal cord injury (SCI) survivors living with low quality of life. Physical inactivity, depression, and chronic pain are major problems faced by SCI survivors discharged from the acute phase of treatment or inpatient rehabilitation. This study aims to evaluate the feasibility, acceptability, and preliminary effects of a Physical-Psychological Integrative (PPI) online group intervention on community-dwelling SCI survivors’ physical activity, depression, and chronic pain. Methods This is a two-arm pilot randomized controlled trial with repeated measures (pre-, post-intervention, and 3-month follow-up) design. Seventy-two participants will be randomly assigned to two study groups. The PPI intervention group will receive a video program for physical activity training and eight-week online group psychological interventions using skills of group-based motivational interviewing and mindfulness-based stress reduction. The control group will receive an eight-week online didactic education programed. Focus-group interviews will be conducted post-intervention to explore their views about acceptance and suggested improvements to the intervention. The feasibility of study procedures and the acceptability of interventions will be evaluated. The effectiveness of the PPI intervention will be evaluated by leisure-time physical activity, depression, chronic pain, exercise efficacy, mindfulness, and quality of life. We will use the generalized estimating equation to assess intervention effects and content analysis for interview data. This study has received ethical approval from the Hong Kong Polytechnic University (HSEARS20210705004) and was registered in ClinicalTrials.gov (NCT05535400). Discussion This study will be the first to provide empirical data on the evaluation of an online-group intervention integrating both physical activity promotion and psychological approaches, aimed at reducing physical inactivity, depression, and chronic pain for community-dwelling SCI survivors in Hong Kong. The findings could provide evidence supporting the use of PPI intervention as a novel online group support, in addressing both the physical and psychological needs of community-dwelling SCI survivors.

irrecoverable neurological loss and severe disabilities that last for the rest of their lives. Prior research has indicated that people with paraplegia/tetraplegia following traumatic SCI have a lower quality of life than the general Hong Kong population and they need more medical care, psychosocial support, and environment adaptation [4]. People with SCI experience various secondary physical and psychological consequences during the long recovery process.
Physical inactivity, depression, and chronic pain are the major challenging problems and have detrimental effects on these people's quality of life and wellbeing. Approximately 50% of the SCI population have no engagement in leisure-time physical activities such as wheeling, therapeutic exercise, or equipment-assisted walking after they are discharged from inpatient rehabilitation, and this inactivity is linked with increased risk for depression, pain, and poor quality of life [5]. Physical inactivity is not only determined by people's levels of injury and severity at post-SCI but also related to their behavioural patterns and psychological conditions [6]. Those with more negative emotions and low levels of self-efficacy will have lower motivations and engagement in physical activities. Depression (caused by a variety of medical, psychological, and social factors) is the most common mood problem in people with SCI, and it interferes with the ability of individuals to engage in daily life activities and affects their life satisfaction [7]. The prevalence rate of depression at post-SCI ranges from 9.8% to 63.9% at post-SCI, which is significantly higher than those of non-SCI counterparts (5.3%-11.3%) [8].
Chronic pain (persisting for more than 12 weeks) also remains a significant problem at post-SCI, with an estimated prevalence rate of around 70%-80% during long-term rehabilitation [9]. Chronic pain has a significant negative impact on the physical and emotional functioning of people with SCI, and a strong interrelationship has been found between pain and depression among people with SCI [10].

A systematic review of 19 clinical trials of activity-based interventions for
people with SCI has demonstrated positive effects on people's mobility, independence, and quality of life [6]. However, most of these trials were conducted in the inpatient rehabilitation or the sub-acute phase of post-SCI.
Very few trials focused on the long-term rehabilitation outcomes of people with SCI living in the community, which might be due to the barriers of transportation and lack of face-to-face interaction with healthcare professionals.
Two pilot trials that integrated physical activities (e.g., home-based aerobic exercise) and telephone counselling from physiotherapists indicated positive effects of an activity-based intervention on patients' functional improvement and physical fitness [11,12]. In addition, previous research also indicated positive effects of physical activities on SCI survivors' mood (e.g., depression) and subjective well-being [12]. People's adherence to the practice of physical activities after community reintegration remains a big challenge and studies highlighted the importance of psychological intervention (i.e., motivational interviewing) in enhancing patients' motivation and adherence to physical activity [12]. Telephone counselling and online face-to-face meetings will be good modalities for overcoming the barriers of not having face-to-face interactions and problems of transportation.
Non-pharmacological interventions (e.g., psychological approaches) for the treatment of depression and pain at post-SCI are effective alternatives/adjunct therapies to pharmacological intervention which are associated with various side effects including constipation, toxicity, and/or increased addiction/abuse [13,14]. Psychological interventions (e.g., cognitive behaviour therapies, mindfulness interventions) have been given much attention in recent research and have shown positive effects in relieving depression, pain intensity, and pain-related disability of people with SCI [15,16]. In addition, psychological interventions can enhance people's self-efficacy and confidence in facing various challenges and stressful situations at post-SCI, as well as improve engagement in physical exercise and rehabilitation [15]. Prior research showed two main waves of psychological interventions for people with SCI including cognitive behaviour therapies and coping skills-based interventions/training. The most recent focus (the third wave) is to apply acceptance-and mindfulnessbased interventions, in order to cultivate 'acceptance' of thoughts, behaviours, and emotions [17]. A recent systematic review of five mindfulness interventions for people with SCI indicated a significant reduction in depressive symptoms and pain-related outcomes [17]. However, conclusions are preliminary given the small number of included studies and moderate-to-high risk of bias in these studies (e.g., small sample sizes or lack of a control group). That said, the current evidence highlights the potential for mindfulness interventions in improving outcomes (i.e., depression and chronic pain), and the need of more high-quality studies in this area.
In summary, there is a considerably large group of community-dwelling SCI survivors in Hong Kong who are having low quality of life [4]. Physical inactivity, depression, and chronic pain are major problems faced by SCI survivors discharged from the acute phase of treatment or inpatient rehabilitation. Psychological factors play pivotal roles in determining people's engagement in post-discharge physical activity, as well as the management of depression and chronic pain. There is a scarcity of research that has addressed both the physical and psychological needs of community-dwelling SCI survivors in Hong Kong. Further, people with SCI living in the community may have great difficulties in engaging in face-to-face group intervention due to their reduced physical function. Online interventions (e.g., video meetings by Zoom) may be a good alternative for community-dwelling SCI survivors to overcome the physical barriers (i.e., transportation), and to enhance their adherence to interventions. Given the above, our team will be the first to develop an onlinegroup intervention that includes both physical activity promotion and psychological approaches (i.e., mindfulness-based skills training and SCIrelated psychoeducation) to address the health needs of community-dwelling SCI survivors in Hong Kong. Specifically, the physical activity component will address participants' rehabilitation needs by enhancing their physical activity and body functions, while the psychological component will promote their subjective well-being and community participation. The integration of the physical and psychological approaches can truly meet community-dwelling SCI survivors' needs [18], as well as fill the research gaps of lacking high-quality randomised controlled trials. Previously, our team has conducted group-based psychosocial interventions (i.e., coping-oriented supportive programme) for people with SCI during inpatient rehabilitation, and the programme resulted in significant improvement of participants' coping ability, mood, and life satisfaction [19,20].
Taken together, the proposed intervention not only can potentially promote physical activities but lower the risk of depression and chronic pain in people with SCI. Proper management of these chronic conditions can further reduce medical costs and healthcare burdens. Our findings will lay the foundation for a fully powered randomized controlled trial which would be a reference for the policymakers to develop innovative and comprehensive community healthcare for people with SCI in Hong Kong. As such, this project can meet the service gaps by providing community health support for people with SCI in Hong Kong, who are highly vulnerable (and maybe marginalized) due to their severe lifelong disability. It will also echo the Hong Kong Food and Health Bureau's strategic direction to stepping up the control of modifiable risk factors (e.g., physical inactivity) for non-communicable diseases, as well as to support the Hong Kong Government's commitment to "fighting against non-communicable diseases on all fronts and alleviating its burden" [21].

b) Aims and Hypotheses to be Tested
This study aims to evaluate the feasibility, acceptability, and preliminary effects of an eight-week Physical-Psychological Integrative (PPI) online-group intervention on physical inactivity, depression, and chronic pain for people with SCI living in the community.
Research hypotheses: when compared with those the control group (online telephone didactic education), participants in the PPI intervention group will indicate significantly greater: Emails/phone call invitations will be sent to potential participants and advertising posters will also be used to encourage them to participate. Eligibility: People with SCI will be included if they are: (1) at least 18 years old; (2) currently living in the community and having SCI for more than 6 months; (3) complete injury at the C6 or below or incomplete injury at any level; (4) having a computer/smartphone with audio-speaking function and Zoom software, and internet access in a secure place; (5) using a wheelchair for at least 2 hours a day and having approval from their physicians to perform exercises; (6) having no problems in hearing, verbal communication and vision; and (7) able to communicate in Cantonese and to provide informed consent.
People with SCI will be excluded if they are: (1) presenting with any significant cognitive impairment or brain injury; (2) engaged in ongoing psychotherapy or any other physiotherapy/exercise/relaxation interventions; (3) physically active for more than 150 minutes per week; and (4) experiencing significant psychotic symptoms, substance misuse or medically unfit for the exercise and psychological programme as diagnosed by their physicians.

Sample size
As this proposed study is to develop and evaluate the feasibility, acceptability, and preliminary effectiveness of the PPI intervention, a widely acceptable sample size (i.e., 30 participants in each study group) for a preliminary analysis to examine intervention feasibility and to estimate a between-group effect will be adopted [22]. Considering a 20% attrition rate, 36 people with SCI per study group (i.e., 72 people in total) will be recruited. A purposive sampling by key informants (containing both participants who completed the whole intervention sessions and those who withdrew from the intervention period) will be conducted for focus-group interviews (i.e., 4-5 participants per group), until saturation of the information was reached.

Randomization and masking
After the completion of the baseline assessment, eligible participants will be randomly allocated to two study groups. The random allocation will be conducted by an independent researcher with an external randomization service (i.e., sealedenvelope.com), using random permuted block sizes (i.e., 4 or 6) to ensure balanced group numbers. Participants will not be blinded due to the nature of the intervention. Participants will be reminded to keep the intervention content confidential and not discuss this with participants in the control group to avoid contamination. Assessor-blind is not adopted as measurements are self- Two audio-tape recorded sessions (i.e., 20 minutes each) of mindfulness practice will be given to the participants for their daily practice. The intervention will be carried out by an experienced social worker trained in psychology, motivational interviewing, and mindfulness-based stress reduction.

The control group
Participants in the control group will receive a video call (approximately 60 minutes each week for eight weeks) from the trained research assistant with psychological background, i.e., to provide general physical and psychological suggestions (e.g., encouragement of performing physical activities, and communication skills with family members/friends, and engagement in the community life). This is to control the contact effects of the PPI intervention.

Study attrition and data fidelity
The research assistant will contact the participants via phone/WhatsApp and encourage them to attend the online meetings as scheduled. Fitbit wristband activity trackers will be used as incentives for the participants to remain in the study. The group intervention attendance and dropout of participants will be monitored by the intervention facilitator, and a logbook will be used to record their attendance. Intervention sessions will be audio-taped with participants' consent for reviews and discussion of improvements among the research team.
A researcher independent of the study execution will be responsible for periodic monitoring of data collection progress, quality, and safety. All adverse events will be identified, reported, and handled cautiously.

Ethical considerations
Ethical approval will be obtained from the Hong Kong Polytechnic University.
This study will be performed in accordance with the Helsinki Declaration.
Written informed consent will be obtained from all participants before the baseline assessments of the study, and will also be obtained from purposely sampled participants prior to all focus-group interviews. Participation is entirely voluntary for people with SCI and they can withdraw from the research at any time without any penalty. Participants' identities and data (information collected and videotape records) will be protected by maintaining anonymity and confidentiality. Only authorized personnel can access the data for analysis.
(iv) Data processing and analysis

Feasibility and acceptability
The feasibility assessment of subject recruitment and follow-up will include (1) time taken to recruit the target sample size; (2) (5) reasons for dropping out will be collected from participants who dropped out.
The acceptability of the intervention will be indicated by (1) adherence rate: the number of PPI intervention sessions practiced divided by the total number of required sessions; (2) adverse events record associated with PPI intervention; and (3) satisfaction: participants' satisfaction with the intervention will be assessed with the Client Satisfaction Questionnaire [25]. The acceptability of the intervention will also be assessed by focus-group interviews with a purposive sample of participants who completed the whole intervention sessions and those who withdrew from the intervention period. Participants' perspectives about the acceptability, strengths, and limitations of the study and suggestions on the improvements of the interventions will be explored.

Preliminary effectiveness
All participants will be assessed at pre-, post-intervention, and 3-month followup by the research assistant. A self-designed form will be used to collect data on participants' socio-demographics and medical history, including age, gender, employment, marital status, ethnicity, cause, level of injury, and time since the injury. The following outcomes/instruments will be used to assess the preliminary effects of the PPI intervention. Effect sizes (e.g., Cohen's d) and confidential intervals will be calculated to estimate the sample size for a future fully powered randomized controlled trial.

Primary outcomes include
Leisure-time Physical Activity. Participants' leisure-time moderated-torigorous physical activity will be assessed by using the Fitbit Orb (San Francisco, IL) which is a wearable, display, triaxial accelerometer that pairs with Bluetooth with compatible smartphones. It can monitor the heartbeat rate of users for each minute. Participants will be asked to wear the Fitbit tracker for more than 10 hours a day (defined as daily adherence) throughout the study period. This accelerometer-based wristband activity tracker has shown its validity in measuring physical activity in cohorts with SCI [26].
Depression. The 9-item Patient Health Questionnaire will be used to measure the participants' depression level. Participants will be asked to rate "how often they were bothered by specific symptoms over the last two weeks" with each item rating from 0 (not at all) to 3 (nearly every day). Higher scores indicate greater symptoms of depression. The scale has indicated satisfactory reliability in the SCI population [16].
Chronic Pain. An 11-point numerical pain rating scale will be used to access pain intensity (in the past week), where zero means no pain and 10 means the worst imaginable pain. The scale has demonstrated good reliability in the Chinese SCI population [20].

Secondary outcomes include:
Exercise Efficacy. The 10-item Chinese version of the self-efficacy for exercise will be used to evaluate participants' confidence level (from 0 not confident to 10 very confident) regarding engaging in regular exercise. The average scores of ten items will be calculated, with the higher scores indicating greater exercise efficacy. The scale demonstrated good reliability and validity in Chinese people using wheelchairs [27].
Mindfulness. The 39-item Five Facet Mindfulness Questionnaire will be used to measure the five aspects of mindfulness including observing, describing, acting with awareness, non-judgmental and non-reactive. Answering on a five-point Likert scale (from 1 never to 5 always true), higher scores denote greater levels of mindfulness. Satisfactory reliability was found for each subscale in the SCI population [28].

Quality of life. The 26-item World Health Organization Quality of Life Brief
Scale will be used for assessing participants' quality of life in four domains including physical health, psychological health, social relationships, and environment. Higher scores indicate greater perceived quality of life with grading on a five-point Likert scale. This scale has demonstrated strong psychometric characteristics of good reliability in the SCI population [28].

Data collection and processing
With participants' written consent, pre-intervention test will be conducted faceto-face (or online if participants cannot come to the study site) by filling out the questionnaires by the participants by participants on their own. Assistance for those who have difficulties in filling out surveys will be provided by their caregivers or research assistants. At post-intervention and 3-month follow-up, the research assistant will use the same set of outcome questionnaires but the evaluation will be online. Focus groups will be conducted online as described above in the 'feasibility and acceptability' section. With their consent, the interviews (and intervention sessions) will be audio-taped for content analysis.

Data analysis
All quantitative data from the pre-and post-tests will be numerically coded, summarized (with descriptive statistics), and analyzed using IBM SPSS 26.
Both intention-to-treat and per-protocol analyses will be performed. Effect sizes of between-group comparisons will be estimated using Cohen's d which is applicable for small sample sizes [29]. Comparison of baseline information between two study groups will be performed by t-test, Mann-Whitney U, and/or Chi-square tests depending on the nature of the data. The generalized estimating equation will be used to assess the changes in the outcome measurements between groups over time, followed by contrast tests. Co-variance (if any found in the baseline comparison) will be adjusted during the analysis of intervention effects. Subgroup analysis will be conducted for certain factors (e.g., complete and incomplete injury or intervention completion and non-completion). Level of significance is set at p<0.05 (2-tailed).
Focus group interview data will be content analyzed. Tape-recorded interviews will be transcribed into Cantonese by one research assistant and cross-checked by the other research assistant. Codes will be discussed and agreed between our team members, combined to form categories/subcategories, and explained with verbatim data. Any discrepancy in coding/category will be discussed and final themes/subthemes will be confirmed by our team. Nonjudgement -Discuss the practice of physical activities -Explore present moment experience -Focused attention on breathing with acceptance and a non-judgmental attitude -Practice breath awareness meditation -Breath awareness meditations began with a broad awareness of the bodily experience of breathing, becoming increasingly focused on more subtle aspects of breathing and encouraged participants to notice when their attention wandered away from the meditation -Homework physical activity, body scan and mindful breathing 4th session Stay present and let go -Discuss the practice of physical activities -Practice the attitude: Stay present and let go -Increase acceptance and compliance with medication -Practice mindfulness movements and -Mindfulness movement and mindful sitting (with breath awareness) -Observe experience with stay present attitude and observe body sensations, feelings and thoughts -Homework: mindful movement and mindful sitting, physical activity 19 mindful sitting 5th session Our thoughts are not real & Response without reacting -Discuss the practice of physical activities -Aware of the thoughts-alternative perspectives of seeing your thoughts and sensations -Integrate mindfulness in managing stress and daily difficulties -Recognize recurring thoughts and stand back from them, without questioning them -Discuss stigma and how to react to discrimination -Continue the practice of body scans and mindful breathing -Recognize negative thoughts -An alternative response to negative thoughts is "mindful, and response without reacting" -Discuss stigma and how to react to negative thoughts and behaviours to discrimination -Homework: recognize negative thoughts and practice mindfulness response without reacting Review the programme and end the session -To encourage participants to persist in practising leisure time activities, and to practice, skills learnt in the mind-body intervention -To build social networks and share the experience with peers -To end the programme -Invitation to outcome assessment -Importance of social networking and sharing experience with peers -Review the mindfulness skills and encourage the continuous practice of physical activity and mind-body interventions -To end the session